Combination Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia

NCT00003602 | Unknown Phase 3

• 3 other identifiers: CDR0000066675RHG-AML97EU-98031
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating older patients with acute myeloid leukemia. PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating older patients with acute myeloid leukemia in first remission.

Conditions

Leukemia; Myelodysplastic Syndromes

Keywords

untreated adult acute myeloid leukemia; refractory anemia with excess blasts; refractory anemia with excess blasts in transformation; secondary acute myeloid leukemia; de novo myelodysplastic syndromes; secondary myelodysplastic syndromes

Interventions

cytarabine DRUG

etoposide DRUG

idarubicin DRUG

mitoxantrone hydrochloride DRUG

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed de novo or secondary acute myeloid leukemia (AML) * Prior myelodysplasia allowed * Refractory anemia with excess blasts (RAEB) OR * RAEB in transformation * No relapsed AML * No chronic granulocytic leukemia in transformation * No CNS disease PATIENT CHARACTERISTICS: Age: * Over 55 Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * Transaminases no greater than 2.5 times ULN Renal: * Creatinine no greater than 2.5 times ULN Cardiovascular: * No severe or uncontrolled cardiac failure Other: * No serious medical, social, or psychological condition * Not HIV 1 or 2 seropositive PRIOR CONCURRENT THERAPY: Biologic therapy: * No plan for future autograft Chemotherapy: * No prior chemotherapy for myelodysplastic syndrome or AML Endocrine therapy: * Not specifed Radiotherapy: * Not specified Surgery: * Not specified Other: * No concurrent aluminum or magnesium-based antacids

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Riverside Haematology Group: lead

Study Sites (1)

Newcastle Upon Tyne Hospitals NHS Trust

Newcastle upon Tyne, England, NE7 7DN, United Kingdom

Location

MeSH Terms

Conditions

Leukemia; Myelodysplastic Syndromes; Anemia, Refractory, with Excess of Blasts

Interventions

Cytarabine; Etoposide; Idarubicin; Mitoxantrone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Anemia, Refractory; Anemia

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Daunorubicin; Anthracyclines; Naphthacenes; Aminoglycosides; Anthraquinones; Anthrones; Anthracenes; Quinones

Study Officials

• Graham Jackson, MD

  Newcastle-upon-Tyne Hospitals NHS Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: March 1, 1998
• Last Updated: September 20, 2013

Record last verified: 2001-01

Locations

GB (1)